CMC Writer

SUMMARY:Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities.This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.JOB DESCRIPTION:Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissionsAuthoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissionsEnsure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.Assess and communicate potential regulatory risks and propose mitigation strategiesUnderstands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.Identify, communicate and escalate potential CMC regulatory issues, as neededHelp establish regulatory CMC submission processes and procedures.Familiar with eCTD format submission filesProject management skill is plusKEY RESPONSIBILITIES:Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.Collaborate with cross-functional teams to gather accurate technical information.Identify and communicate potential regulatory risks; propose mitigation strategies.Support process improvement initiatives for CMC submission workflows.QUALIFICATIONS:Education: Bachelors or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management.Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities.Familiarity with global regulatory frameworks and eCTD submissions.Excellent technical writing, communication, and organizational skills.Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).Veeva Vault, Smartsheet are plusPREFERRED SKILLS:Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings.Ability to interpret and apply regulatory guidelines effectively.Strong project management and stakeholder communication skills.